SOL Pharmaceuticals – electronic records

SOL Pharmaceuticals – Active pharmaceutical ingredients – Human Drugs

For example, values in at least two … areas were altered. Altered values were written under computer generated values on the … and used in the potency calculations. Review of the electronic data confirmed the incorrect values, which were part of your submission to DMF

Your company has not provided explanations for many of these record deviations. In four cases, typewritten dates (21/10/1999) were pasted over computer generated dates (04/01/1980) on [_____] You stated that these [_____] were generated on 04/01/2000 (day/month/year) and that the year printed out was a result of a Y2K glitch. But, the date pasted on the [_____] was 21/10/1999. Either this explanation or the date the [_____] was generated is wrong. Further, the [_____] use log has no entries from August 5 to December 17, 1999. This also indicates that the 21/10/1999 date is wrong. In addition, our investigative team found it impossible to trace computer generated [_____] because they were not date stamped.

Division: Rockville, MD

SoftwareCPR Keywords: Part 11 Electronic Records

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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